---
kind: "section"
citation: "21 C.F.R. § 335.50"
title: "21"
number: "335.50"
heading: "Labeling of antidiarrheal drug products."
url: "https://uscodex.org/cfr/21/335.50"
---

# §335.50. Labeling of antidiarrheal drug products.

- (a) **Statement of identity.** The labeling of the product contains the established name of the drug, if any, and identifies the product either as an “antidiarrheal” or “for diarrhea.”
- (b) **Indications.** The labeling of the product states, under the heading “Use,” one or more of the phrases listed in this [paragraph (b)](#b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this [paragraph (b)](#b) may also be used, as provided in [§ 330.1(c)(2)](/cfr/21/330.1.md?p=c-2) of this chapter, subject to the provisions of [section 502](/cfr/21/502.md) of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in [section 301(d)](/cfr/21/301.md?p=d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of [section 505(a)](/cfr/21/505.md?p=a) of the act.
  - (1) **For products containing bismuth subsalicylate identified in § 335.10(a).** The labeling states [select one of the following: “controls” or “relieves”] [select one or both of the following: “diarrhea” or “travelers' diarrhea”]. If both “diarrhea” and “travelers' diarrhea” are selected, each shall be preceded by a bullet in accordance with § [201.66(b)(4)](/cfr/21/201.66.md?p=b-4) and [(d)(4)](/cfr/21/201.66.md?p=d-4) of this chapter and the heading “Uses” shall be used.
  - (2) **For products containing kaolin identified in § 335.10(b).** The labeling states “helps firm stool within 24 to 48 hours”.
  - (3) **Additional indications—**
    - (i) When any additional indications are used, the heading “Uses” shall be used and each listed use shall be preceded by a bullet in accord with [§ 201.66(b)(4)](/cfr/21/201.66.md?p=b-4) of this chapter.
    - (ii) In addition to the indication in [paragraph (b)(1)](#b-1) of this section, one or both of the following may be used for products containing bismuth subsalicylate in [§ 335.10(a)](/cfr/21/335.10.md?p=a): “[bullet] reduces number of bowel movements” “[bullet] helps firm stool”.
- (c) **Warnings.** The labeling of the product contains the following warnings under the heading “Warnings”:
  - (1) **For products containing any ingredient identified in § 335.10.**
    - (i) “Do not use if you have [bullet] bloody or black stool”.
    - (ii) “Ask a doctor before use if you have [bullet] fever [bullet] mucus in the stool”.
  - (2) **For products containing bismuth subsalicylate identified in § 335.10(a).**
    - (i) The following shall appear in accordance with [§ 201.66(c)(5)(ii)](/cfr/21/201.66.md?p=c-5-ii) of this chapter.
      - (A) The Reye's syndrome warning in [§ 201.314(h)](/cfr/21/201.314.md?p=h) of this chapter.
      - (B) “Allergy alert: Contains salicylate. Do not take if you are [bullet] allergic to salicylates (including aspirin), [bullet] taking other salicylate products”.
    - (ii) “Do not use if you have [bullet] an ulcer [bullet] a bleeding problem”.
    - (iii) “Ask a doctor or pharmacist before use if you are taking any drug for [bullet] anticoagulation (thinning the blood) [bullet] diabetes [bullet] gout [bullet] arthritis”.
    - (iv) “When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur”.
    - (v) “Stop use and ask a doctor if [bullet] symptoms get worse [bullet] ringing in the ears or loss of hearing occurs [bullet] diarrhea lasts more than 2 days”.
  - (3) **For products containing kaolin identified in § 335.10(b).**
    - (i) “Ask a doctor or pharmacist before use if you are taking any other drugs. Try to use at least 3 hours before or after taking any other drugs.”
    - (ii) “Stop use and ask a doctor if [bullet] symptoms get worse [bullet] diarrhea lasts more than 2 days”.
- (d) **Directions.** The labeling of the product contains the following information under the heading “Directions”:
  - (1) **For products containing any ingredient identified in § 335.10.** The labeling states “[bullet] drink plenty of clear fluids to help prevent dehydration caused by diarrhea”.
  - (2) **For products containing bismuth subsalicylate identified in § 335.10(a).** The labeling states “[bullet] adults and children 12 years and over:” 525 milligrams “every 1/2 to 1 hour, or” 1,050 milligrams “every hour as needed [bullet] do not exceed” 4,200 milligrams “in 24 hours [bullet] use until diarrhea stops but not more than 2 days [bullet] children under 12 years: ask a doctor”.
  - (3) **For products containing kaolin identified in § 335.10(b).** The labeling states “[bullet] adults and children 12 years and over:” 26.2 grams “after each loose stool [bullet] continue to take every 6 hours until stool is firm but not more than 2 days [bullet] do not exceed” [262 grams] “in 24 hours [bullet] children under 12 years of age: ask a doctor”.
- (e) **Products that meet the criteria established in § 201.66(d)(10) of this chapter.** The information described in [§ 201.66(c)](/cfr/21/201.66.md?p=c) of this chapter shall be printed in accordance with the following specifications.
  - (1) The labeling shall meet the requirements of [§ 201.66(c)](/cfr/21/201.66.md?p=c) of this chapter except that the information in [§ 201.66(c)(3)](/cfr/21/201.66.md?p=c-3) of this chapter may be omitted, and the information in § [201.66(c)(5)](/cfr/21/201.66.md?p=c-5) and [(c)(6)](/cfr/21/201.66.md?p=c-6) of this chapter may be presented as follows:
    - (i) The words “Contains salicylate.” may be omitted from the warning in [§ 335.50(c)(2)(i)(B)](#c-2-i-B).
    - (ii) The subheading “When using this product” in [§ 335.50(c)(2)(iv)](#c-2-iv) may be omitted.
    - (iii) The words “continue to” may be omitted from the directions in [§ 335.50(d)(3)](#d-3).
  - (2) The labeling shall be printed in accordance with the requirements of [§ 201.66(d)](/cfr/21/201.66.md?p=d) of this chapter except that any requirements related to [§ 201.66(c)(3)](/cfr/21/201.66.md?p=c-3) of this chapter and the bullet in the warning in [§ 335.50(c)(1)(i)](#c-1-i) may be omitted.

## Notes

### Amendments

[68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Source

Source: 68 FR 18881, April 17, 2003, unless otherwise noted.

### Amendments

[68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004]